Kim J, Bissonnette R, Lee J, Correa da Rosa J, Suarez-Farinas M, Lowes MA, Krueger JG The Spectrum of Mild to Severe Psoriasis Vulgaris Is Defined by a Common Activation of IL-17 Pathway Genes, but with Key Differences in Immune Regulatory Genes. J Invest Dermatol. 2016 Nov;136(11):2173-2182. doi: 10.1016/j.jid.2016.04.032. Epub 2016 May 13.
Kim J, Kim DJ, Ortenzio FS, Dare L, Frank C, Kost RG, Lowes MA Patients With Psoriasis and Personalized Trade-offs in Treatment Decisions-Lessons Learned From Focus Groups. JAMA Dermatol. 2016 Jun 1;152(6):720-2. doi: 10.1001/jamadermatol.2016.0501. No abstract available.
Kim J, Krueger JG Highly Effective New Treatments for Psoriasis Target the IL-23/Type 17 T Cell Autoimmune Axis. Annu Rev Med. 2017 Jan 14;68:255-269. doi: 10.1146/annurev-med-042915-103905. Epub 2016 Sep 23.
Kim J, Lee J, Gonzalez J, Fuentes-Duculan J, Garcet S, Krueger JG Proportion of CD4+CD49b+LAG-3+ Type 1 Regulatory T Cells in the Blood of Psoriasis Patients Inversely Correlates with Psoriasis Area and Severity Index. J Invest Dermatol. 2018 Dec;138(12):2669-2672. doi: 10.1016/j.jid.2018.05.021. Epub 2018 Jun 8. No abstract available.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.